Incore Co., Ltd. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Hemoblock_S (Prescription); Hemoblock_S (OTC)510(k)Apr 19, 2024	—	510(k)Substantially Equivalent (Traditional)	Apr 19, 2024
CORE-INJECTOR510(k)Dec 21, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 21, 2022
CORE-SNARE510(k)Nov 21, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 21, 2022
CORE-SPORT510(k)Sep 28, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 28, 2022
CORE-CLIP510(k)Jun 23, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 23, 2022
CORE-Trocar510(k)Jun 21, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 21, 2022